DATA ANALYTICS & VISUALIZATION
Argus, ARISg, and LSMV data — turned into decisions.
Audit-ready reporting, automated delivery, and custom regulatory outputs — built on the tools your safety team already runs.
Discuss a reporting assessmentWHAT WE HAVE BUILT, AND WHEN IT LANDS
Aggregate reporting
PBRER/PSUR/DSUR/PADER · Standard safety listings · Post-marketing experience tabulations · CIOMS II line listings · Medication errors by SMQ
Signal, reconciliation & review
Signal detection run · SAE reconciliation, clinical vs safety · Medical review listings · Pregnancy reports
Submission & compliance
Compliance report · Worklist and pending transmissions · Submission compliance · Invalid cases · Action-item tracking
System oversight
Audit-log extracts · User access · Configuration snapshots · Study configuration · Vendor quality
DELIVERED IN
SpotfirePower BITableauCognosSAP BusinessObjectsOBIEE
FROM EXTRACT TO ANSWER
The rebuild behind every new question.
Forty-five seconds on what changes when the pivot logic is authored once — around your portfolio and the regulations you report under — instead of rebuilt in a spreadsheet every time someone asks something new.
WHAT CHANGED FOR OUR CLIENTS
Our latest improvements, explained properly.
A selection of recent work. We have delivered a great deal more than this — these are the pieces worth explaining rather than listing.
Why we build custom CIOMS and MedWatch outputs
Argus ships both forms, and so does every other serious safety system. Ours exist alongside them, and the reasons have less to do with the form itself than with everything that surrounds it — how it is versioned, where it has to land, and what it has to be able to prove about itself afterwards.
THE DECOUPLING THAT MATTERS MOST
THE SITUATION THIS SOLVES
A release lands with updated CIOMS and MedWatch templates. The templates are all that changed — but taking the release is what it costs to get them: re-qualification, regression testing, a change window and downtime nobody budgeted for, to obtain a document layout. Keeping the forms as change-controlled reports separates the two decisions.
Form versions, independent of platform versions
When a release brings updated CIOMS or MedWatch templates, the templates are what changed — but a platform upgrade is what it takes to get them. As reports, the forms version on their own schedule, so a new template is a report up-version with its own verification rather than a system project.
Delivered where the readers are
Outputs are delivered straight into the shared drives and document systems where the people who use them already work, on a schedule rather than on request.
Carrying their own provenance
Every output opens with the parameters it was run with, the filters that could not be overridden, the logic applied, and who ran it when — so it can account for itself months later.
One report that answers a hundred questions
Most safety questions are the same question with different boundaries. A standard safety report built properly takes those as parameters — period, product, population, terminology, data quality — and returns a line listing plus tabulations that agree because they came from one run. Validate it once, and the hundredth question costs nothing.
Everyday questions, without a new request
Has this term come up before in this product, at any level of the hierarchy? What did last quarter look like against the one before? Which countries, which report types, which age bands? Each is a query someone would otherwise write. Parameterized properly, they are one report with different answers.
Signal detection
Standardized queries at either scope, terminology selectable at any level of the hierarchy, and control over how those selections combine. The output also surfaces which terms come up most often among affected cases, and what was reported alongside them.
Risk characterization
Demographic breakdowns across the cumulative period, affected cases set against the wider population, and listedness resolved against whichever reference document governs that case type rather than a single one applied to everything. That distinction is what makes an unlisted count mean anything.
Periodic report authoring
Tabulations laid out the way a PBRER or DSUR needs them: down the terminology hierarchy, split by source category, seriousness, and interval against cumulative — produced in one run, so the two periods cannot disagree. Event and case counts stay distinct, and causality and blinding rules follow the case type rather than being applied by hand each cycle.
WHY IT HOLDS UP
A report like this states its own rules on the face of the output: the filters that cannot be overridden, how excluded and blinded cases are treated, how incomplete values are rendered. Someone reading it a year later can see what it counted and why — the difference between a number and a number you can defend.
Data quality checks that run to a written standard
Case data quality is usually checked by whoever notices. A reviewer spots a missing date, someone else catches a coding inconsistency, and the checks that get run depend on who is looking and how much time is left before the submission. Nothing records what was checked, so nothing can show that it was.
WHAT WE BUILT
We specified the quality checks as a report. Each check is defined once — what it looks for, which cases it applies to, and what counts as a failure — and the same set runs every cycle against whichever period, product or study is selected. The output gives counts per check and the case numbers behind them, so a discrepancy can be opened rather than searched for.
The same checks every time
The check set is written down, not remembered. It does not shrink because a deadline is close, and it does not vary with who runs it.
Counts and the cases behind them
Every check reports how many cases failed it and lists them, so the finding is actionable instead of a number someone has to go and reproduce.
Found before submission, not after
Run on a schedule against an open period, the check set surfaces data problems while they are still cheap to fix — rather than as a question from an authority later.
The maintenance a custom report quietly creates
Any report that resolves MedDRA terminology itself — grouping by system organ class, or selecting on standardized query membership — has to name a dictionary schema in its SQL, and an upgrade lands the new dictionary in a new one. In a suite we inherited, several reports named it explicitly. Every upgrade meant hand-editing each of them, and one missed edit would render retired terminology against cases already recoded.
We introduced a stable schema the reports point at permanently, then verified it by reconciling row counts across every dictionary table. The refresh and its verification went into the recurring upgrade procedure with an owner assigned — because the fix that matters is the one still working after the people who made it have moved on.
We introduced a stable schema the reports point at permanently, then verified it by reconciling row counts across every dictionary table. The refresh and its verification went into the recurring upgrade procedure with an owner assigned — because the fix that matters is the one still working after the people who made it have moved on.
HOW A REPORT IS BUILT
Specified first, written second.
A custom report that was never specified is a report nobody can validate, and nobody can change later without guessing what it was for.
Step 01
Agree the question
What the report has to answer, and for whom.
Step 02
Write the specification
Fields, filters, logic and layout, agreed before build.
Step 03
Build it
Against the safety database, on the platform already in place.
Step 04
Qualify it
Tested against known cases, with the results recorded.
Step 05
Hand over the logic
The report, its specification and its query, together.
PLATFORMS AND OUTPUTS
Built on the tooling you already run.
Reporting belongs where the business already works. We do not ask you to adopt a platform to read your own safety data.
SAFETY SYSTEMSArgus SafetyArgus Insight & MartARISg / IRTLSMVClinical safety
PLATFORMSCognosPower BITableauSpotfireSQL and stored procedures
OUTPUTSPDFExcelCSVXMLScheduled deliveryOn demand
WHAT’S INCLUDED
SAFETY SYSTEMS
Argus Safety, Insight & Mart reporting
ARISg and LSMV reporting
Third-party safety reporting tool consulting
REPORTING PLATFORMS
IBM Cognos, SAP BusinessObjects & OBIEE
Interactive reporting — Power BI, Tableau & Spotfire
Custom and ad-hoc reporting
Report delivery automation & integration
AGGREGATE & PERIODIC REPORTS
PBRER and PSUR
DSUR
PADER
Post-marketing experience reports
Medication error reports (SMQ-based)
LINE LISTINGS & CASE REPORTS
CIOMS II line listings
SUSAR reports
Pregnancy reports
Underlying disease listings and tabulations
Medical review listings
Standard safety reports
COMPLIANCE & OVERSIGHT
Submission compliance reports
Safety oversight reports
Worklist and workflow reports
Action item tracking
Invalid and pending E2B case reports
RECONCILIATION & DATA QUALITY
Clinical and safety SAE reconciliation
Case quality-control reports
E2B source data reports
AUDIT & INSPECTION READINESS
Audit-trail and audit log reports
Configuration audit log reports
User access reports
Study and business configuration reports
Vendor quality reports
Validated safety data retrieval procedure
Ready to see your safety data clearly?
Talk to us about the listings, tabulations and periodic outputs your team actually needs.
Discuss a reporting assessmentCONTACT
© 2020–2026 Merakee BI Analytics Ltd.
Mississauga, Ontario, Canada
DATA ANALYTICS & VISUALIZATION
Argus, ARISg, and LSMV data — turned into decisions.
Audit-ready reporting, automated delivery, and custom regulatory outputs — built on the tools your safety team already runs.
Discuss a reporting assessmentWHAT WE HAVE BUILT, AND WHEN IT LANDS
Aggregate reporting
PBRER/PSUR/DSUR/PADER · Standard safety listings · Post-marketing experience tabulations · CIOMS II line listings · Medication errors by SMQ
Signal, reconciliation & review
Signal detection run · SAE reconciliation, clinical vs safety · Medical review listings · Pregnancy reports
Submission & compliance
Compliance report · Worklist and pending transmissions · Submission compliance · Invalid cases · Action-item tracking
System oversight
Audit-log extracts · User access · Configuration snapshots · Study configuration · Vendor quality
DELIVERED IN
SpotfirePower BITableauCognosSAP BusinessObjectsOBIEE
FROM EXTRACT TO ANSWER
The rebuild behind every new question.
Forty-five seconds on what changes when the pivot logic is authored once — around your portfolio and the regulations you report under — instead of rebuilt in a spreadsheet every time someone asks something new.
WHAT CHANGED FOR OUR CLIENTS
Our latest improvements, explained properly.
A selection of recent work. We have delivered a great deal more than this — these are the pieces worth explaining rather than listing.
Why we build custom CIOMS and MedWatch outputs
Argus ships both forms, and so does every other serious safety system. Ours exist alongside them, and the reasons have less to do with the form itself than with everything that surrounds it — how it is versioned, where it has to land, and what it has to be able to prove about itself afterwards.
THE DECOUPLING THAT MATTERS MOST
THE SITUATION THIS SOLVES
A release lands with updated CIOMS and MedWatch templates. The templates are all that changed — but taking the release is what it costs to get them: re-qualification, regression testing, a change window and downtime nobody budgeted for, to obtain a document layout. Keeping the forms as change-controlled reports separates the two decisions.
Form versions, independent of platform versions
When a release brings updated CIOMS or MedWatch templates, the templates are what changed — but a platform upgrade is what it takes to get them. As reports, the forms version on their own schedule, so a new template is a report up-version with its own verification rather than a system project.
Delivered where the readers are
Outputs are delivered straight into the shared drives and document systems where the people who use them already work, on a schedule rather than on request.
Carrying their own provenance
Every output opens with the parameters it was run with, the filters that could not be overridden, the logic applied, and who ran it when — so it can account for itself months later.
One report that answers a hundred questions
Most safety questions are the same question with different boundaries. A standard safety report built properly takes those as parameters — period, product, population, terminology, data quality — and returns a line listing plus tabulations that agree because they came from one run. Validate it once, and the hundredth question costs nothing.
Everyday questions, without a new request
Has this term come up before in this product, at any level of the hierarchy? What did last quarter look like against the one before? Which countries, which report types, which age bands? Each is a query someone would otherwise write. Parameterized properly, they are one report with different answers.
Signal detection
Standardized queries at either scope, terminology selectable at any level of the hierarchy, and control over how those selections combine. The output also surfaces which terms come up most often among affected cases, and what was reported alongside them.
Risk characterization
Demographic breakdowns across the cumulative period, affected cases set against the wider population, and listedness resolved against whichever reference document governs that case type rather than a single one applied to everything. That distinction is what makes an unlisted count mean anything.
Periodic report authoring
Tabulations laid out the way a PBRER or DSUR needs them: down the terminology hierarchy, split by source category, seriousness, and interval against cumulative — produced in one run, so the two periods cannot disagree. Event and case counts stay distinct, and causality and blinding rules follow the case type rather than being applied by hand each cycle.
WHY IT HOLDS UP
A report like this states its own rules on the face of the output: the filters that cannot be overridden, how excluded and blinded cases are treated, how incomplete values are rendered. Someone reading it a year later can see what it counted and why — the difference between a number and a number you can defend.
Data quality checks that run to a written standard
Case data quality is usually checked by whoever notices. A reviewer spots a missing date, someone else catches a coding inconsistency, and the checks that get run depend on who is looking and how much time is left before the submission. Nothing records what was checked, so nothing can show that it was.
WHAT WE BUILT
We specified the quality checks as a report. Each check is defined once — what it looks for, which cases it applies to, and what counts as a failure — and the same set runs every cycle against whichever period, product or study is selected. The output gives counts per check and the case numbers behind them, so a discrepancy can be opened rather than searched for.
The same checks every time
The check set is written down, not remembered. It does not shrink because a deadline is close, and it does not vary with who runs it.
Counts and the cases behind them
Every check reports how many cases failed it and lists them, so the finding is actionable instead of a number someone has to go and reproduce.
Found before submission, not after
Run on a schedule against an open period, the check set surfaces data problems while they are still cheap to fix — rather than as a question from an authority later.
The maintenance a custom report quietly creates
Any report that resolves MedDRA terminology itself — grouping by system organ class, or selecting on standardized query membership — has to name a dictionary schema in its SQL, and an upgrade lands the new dictionary in a new one. In a suite we inherited, several reports named it explicitly. Every upgrade meant hand-editing each of them, and one missed edit would render retired terminology against cases already recoded.
We introduced a stable schema the reports point at permanently, then verified it by reconciling row counts across every dictionary table. The refresh and its verification went into the recurring upgrade procedure with an owner assigned — because the fix that matters is the one still working after the people who made it have moved on.
We introduced a stable schema the reports point at permanently, then verified it by reconciling row counts across every dictionary table. The refresh and its verification went into the recurring upgrade procedure with an owner assigned — because the fix that matters is the one still working after the people who made it have moved on.
HOW A REPORT IS BUILT
Specified first, written second.
A custom report that was never specified is a report nobody can validate, and nobody can change later without guessing what it was for.
Step 01
Agree the question
What the report has to answer, and for whom.
Step 02
Write the specification
Fields, filters, logic and layout, agreed before build.
Step 03
Build it
Against the safety database, on the platform already in place.
Step 04
Qualify it
Tested against known cases, with the results recorded.
Step 05
Hand over the logic
The report, its specification and its query, together.
PLATFORMS AND OUTPUTS
Built on the tooling you already run.
Reporting belongs where the business already works. We do not ask you to adopt a platform to read your own safety data.
SAFETY SYSTEMSArgus SafetyArgus Insight & MartARISg / IRTLSMVClinical safety
PLATFORMSCognosPower BITableauSpotfireSQL and stored procedures
OUTPUTSPDFExcelCSVXMLScheduled deliveryOn demand
WHAT’S INCLUDED
SAFETY SYSTEMS
Argus Safety, Insight & Mart reporting
ARISg and LSMV reporting
Third-party safety reporting tool consulting
REPORTING PLATFORMS
IBM Cognos, SAP BusinessObjects & OBIEE
Interactive reporting — Power BI, Tableau & Spotfire
Custom and ad-hoc reporting
Report delivery automation & integration
AGGREGATE & PERIODIC REPORTS
PBRER and PSUR
DSUR
PADER
Post-marketing experience reports
Medication error reports (SMQ-based)
LINE LISTINGS & CASE REPORTS
CIOMS II line listings
SUSAR reports
Pregnancy reports
Underlying disease listings and tabulations
Medical review listings
Standard safety reports
COMPLIANCE & OVERSIGHT
Submission compliance reports
Safety oversight reports
Worklist and workflow reports
Action item tracking
Invalid and pending E2B case reports
RECONCILIATION & DATA QUALITY
Clinical and safety SAE reconciliation
Case quality-control reports
E2B source data reports
AUDIT & INSPECTION READINESS
Audit-trail and audit log reports
Configuration audit log reports
User access reports
Study and business configuration reports
Vendor quality reports
Validated safety data retrieval procedure
Ready to see your safety data clearly?
Talk to us about the listings, tabulations and periodic outputs your team actually needs.
Discuss a reporting assessmentCONTACT
© 2020–2026 Merakee BI Analytics Ltd.
Mississauga, Ontario, Canada